Use Of SB424323 With Aspirin In Non-Valvular Atrial Fibrillation In Patients At A Low Or Intermediate Risk For Stroke

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00240643
First received: October 14, 2005
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

This study will allow determination of the pharmacokinetic and pharmacodynamics of SB424323 in a relevant population. The data from this study will be used along with other data to aid in choosing the most appropriate dose for the later phase study.


Condition Intervention Phase
Fibrillation, Atrial
Atrial Fibrillation
Drug: SB424323
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Relationship between anti IIa (a biomarker)and the dose of SB424323.

Secondary Outcome Measures:
  • Blood levels of SB424323 during the study. Number of strokes, transient ischemic attacks or systemic embolism during the study. Changes in laboratory tests during the study.

Estimated Enrollment: 640
Study Start Date: November 2005
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB424323
    Other Name: SB424323
Detailed Description:

A randomized, double blind, double dummy, parallel group, placebo controlled study to evaluate the pharmacodynamic and pharmacokinetic response and safety and tolerability of SB424323 (250 mg, 375 mg and 500 mg) administered twice daily for 16 weeks, on top of aspirin (325 mg, qd) in men and women with non valvular atrial fibrillation at a low or intermediate risk for stroke

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with non valvular atrial fibrillation and any of the following:
  • </= 60 years old with no heart disease.
  • 60 years old with heart disease but no risk factors.
  • >/=60 years old and </=75 years old with no risk factors and no heart disease.
  • Must be able to take aspirin.

Exclusion Criteria:

  • Previous heart attack or stroke.
  • History of high blood pressure, diabetes or a prior blood clot.
  • Liver or kidney disease.
  • Need for anti-thrombotic or anti-platelet drugs.
  • Need for cardiovascular medicines.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240643

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Mobile, Alabama, United States, 36608
United States, Michigan
GSK Investigational Site
Troy, Michigan, United States, 48098
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44313
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
United States, Pennsylvania
GSK Investigational Site
Camp Hill, Pennsylvania, United States, 17011
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
GSK Investigational Site
Houston, Texas, United States, 77030
United States, Washington
GSK Investigational Site
Walla Walla, Washington, United States, 99362
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1180AAX
GSK Investigational Site
Capital Fefderal, Buenos Aires, Argentina
GSK Investigational Site
Cordoba, Córdova, Argentina, 5003
GSK Investigational Site
Córdoba, Córdova, Argentina, 5000
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Buenos Aires, Argentina, 1704
GSK Investigational Site
Buenos Aires, Argentina, 1428
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1221
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, 1405
GSK Investigational Site
Moron-Provincia de Buenos Aires, Argentina, 1709
Belgium
GSK Investigational Site
Antwerpen, Belgium, 2020
GSK Investigational Site
Linkebeek, Belgium, 1630
Brazil
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Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
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São Paulo, Brazil, 04024-002
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 5R3
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Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
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Burlington, Ontario, Canada, L7M 4Y1
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Grimsby, Ontario, Canada, L3M 1P3
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Hamilton, Ontario, Canada, L8P 3B6
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Newmarket, Ontario, Canada, L3Y 8C3
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Toronto, Ontario, Canada, M3J 1N2
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2G8
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Longueuil, Quebec, Canada, J4K 1E3
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Montreal, Quebec, Canada, H2L 4M1
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St-Lambert, Quebec, Canada, J4P 2H4
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Trois Rivières, Quebec, Canada, G8T 7A1
Denmark
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Aarhus, Denmark, DK-8000
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Frederiksberg, Denmark, 2000
Estonia
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Tallinn, Estonia, 13419
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Tartu, Estonia, 51014
France
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Créteil, France, 94000
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Mont de Marsan, France, 40000
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Toulouse, France, 31300
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Tours, France, 37000
Germany
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Kuenzing, Bayern, Germany, 94550
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Northeim, Niedersachsen, Germany, 37154
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Weyhe-Leeste, Niedersachsen, Germany, 28844
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Wolmirstedt, Sachsen-Anhalt, Germany, 39326
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Chemnitz, Sachsen, Germany, 09113
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Ebersbach, Sachsen, Germany, 02730
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Koenigsbrueck, Sachsen, Germany, 01936
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Leipzig, Sachsen, Germany, 04177
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Leipzig, Sachsen, Germany, 04299
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Leisnig, Sachsen, Germany, 04703
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Markkleeberg, Sachsen, Germany, 04416
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Bad Segeberg, Schleswig-Holstein, Germany, 23795
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Jena, Thueringen, Germany, 07743
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Berlin, Germany, 12163
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Berlin, Germany, 10117
Greece
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Athens, Greece, 115 28
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Athens, Greece, 123 51
Hungary
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Sopron, Hungary, 9400
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Szolnok, Hungary, 5004
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Szolnok, Hungary, 5000
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Székesfehérvár, Hungary, 8000
India
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Bangalore, India
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Bangalore, India, 560034
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Hyderabad, India, 500063
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Mumbai, India, 400008
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New Delhi, India, 110065
Italy
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Catanzaro, Calabria, Italy, 88100
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Caserta, Campania, Italy, 81100
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Roma, Lazio, Italy, 00163
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Città della Pieve (PG), Umbria, Italy, 06062
Korea, Republic of
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Kwangju, Korea, Republic of
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 152-703
Latvia
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Riga, Latvia, LV 1002
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Riga, Latvia, LV1001
Mexico
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Mexico, Mexico, 11850
Netherlands
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Delft, Netherlands, 2625 AD
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Den Haag, Netherlands, 2597 AX
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Utrecht, Netherlands, 3582 KE
New Zealand
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Auckland, New Zealand
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Christchurch, New Zealand, 8001
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Hamilton, New Zealand, 2001
GSK Investigational Site
Takapuna, Auckland, New Zealand, 1309
Norway
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Elverum, Norway, 2408
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Oslo, Norway, N-0160
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Skien, Norway, N-3710
Romania
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Bucharest, Romania, 020125
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Bucuresti, Romania
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Targu-Mures, Romania
Spain
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Alicante, Spain, 03114
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Alicante, Spain, 03010
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Barcelona, Spain, 08036
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Cadiz, Spain, 11009
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Leganes, Spain
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Madrid, Spain, 28035
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Madrid, Spain, 28006
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San Juan De Alicante, Spain, 3550
Sweden
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Göteborg, Sweden, SE-413 45
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Stockholm, Sweden, SE-111 57
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Uppsala, Sweden, SE-751 85
Taiwan
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Taipei, Taiwan, 112
Thailand
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Bangkok, Thailand, 10400
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Chiangmai, Thailand, 50200
United Kingdom
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Glasgow, Lanarkshire, United Kingdom, G11 6NT
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Harrow, Middlesex, United Kingdom, HA1 1QL
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Northwood, Middlesex, United Kingdom, HA6 2RN
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Birmingham, West Midlands, United Kingdom, B18 7QH
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Antrim, United Kingdom, BT41 2RL
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Dundee, United Kingdom, DD1 9SY
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Manchester, United Kingdom, M23 9LT
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York, United Kingdom, YO31 8HE
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00240643     History of Changes
Other Study ID Numbers: 101724
Study First Received: October 14, 2005
Last Updated: February 11, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
non valvular atrial fibrillation
stroke
aspirin

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014